FDA recall Z-0949-2021

Product

Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307

Reason for recall

Due to a manufacturing error, there is a potential that sutures may exhibit inadequate tensile strength. This could potentially lead to intra-operative and post-operative complications such as suture break or wound dehiscence.

Distribution

US: NJ OUS: Germany, Croatia, Italy, India, Poland and Spain.

Key facts

Status

Terminated

Initiation date

2020-12-09

Report date

2021-02-10

Termination date

2023-04-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Portland, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0949-2021